FreeStyle CoPilot Web Based Data Management System, and FreeStyle CoPilot Health Management System,Versions 1 and 2. Web-based software system, no packaging.
FDA Recall Z-1594-05 · Posted 2005-10-01
Recalling FirmAbbott Diabetes Care, Inc.
Recall StatusTerminated
Product CodeLFR
Date Initiated2005-08-30
Date Terminated2006-05-16
Product QuantityProduct is downloadable software
Reason for Recall
Downloadable software obtained from the firm's website displays user data (including but not limited to insulin levels and pump statistics data) in a matter that may be misinterpreted and result in mistreatment of therapy.
Firm Action
On 8/30/05, the firm initiated the recall and its notification was via web postings and phone calls requesting discontinuation of the FreeStyle CoPilot from the website.
A follow-up letter will be sent to registered users advising them of the issues and instructing them to not use CoPilot.
Root Cause
Other
Distribution Pattern
Software, distributed from website via clicking through an agrement to use only for informational purposes, and not as a substitute for professional medical advice treatment or diagnosis.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.